Bioethics and Law Forum
http://www.100md.com
《男科医学杂志》
North Wales, Pennsylvania
Ladden and Laleh Bijani were 29-year-old Iranian twin sisters conjoined at the head. Educated, spirited, ambitious, and singularly determined to lead individual lives, they sought to be separated. Some doctors rejected their plea for separation, while others tried to dissuade them because of the high risk of death for either or both of the sisters. Finally, because of their stoic persistence in pursuit of their singular goal to completely be two, a team of physicians assembled at Raffles Hospital in Singapore. With grins from ear to ear, the women eagerly entered the hospital and excitedly embraced the surgery. Although ultimately separated, they never got to revel in achieving their goal of total autonomy. Sadly, both women bled to death during the 50-hour surgery.
As with most efforts that end in tragedy, the "Monday Morning Quarterbacks (QBs)" began their pontifications shortly thereafter. For example, Mark Siegler of the University of Chicago's Maclean Ethics Center stated plainly that despite the twins [informed] consent, the operation violated ethical standards for experimental surgery because it was not medically necessary and the 50% risk of death was "too high".1 He further elaborated to justify his position, that, "you need more than an autonomous choice on the part of the patient[s],... you need responsible judgement on the part of the surgeon."2 Where Monday Morning QB Siegler expressed ethical concerns, Dr. Benjamin Carson, a Johns Hopkins pediatric neurosurgeon, who initially felt compelled to help the twins because he "was convinced they would seek separation no matter who performed the surgery,"3 expressed technical medical concerns. The operation, he opined, should have been performed in "stages over the course of weeks" rather than "all at once".4 The need for a change in procedure became apparent during the operation and given such, the physicians contemplated stopping, placing the twins in intensive care, and proceeding with the surgery in stages. However, instead of heeding their own medical judgment, the physicians consulted the representative the twins had appointed to make decisions, on their behalf, when they were unable to do so. Because the representative insisted, "the sisters would want the separation to proceed no matter what,"5 the physicians continued.
Other than hindsight and personal opinion, do these arguments have merit? Should separating otherwise healthy adults conjoined at the head ever be undertaken? Were the high risk of death and the physicians ceding their medical decision-making autonomy to the sisters' representative the only medical/ethical concerns? Whose ethical standards take precedent? The sisters'? The physicians'? Western medicine's? Are there any universal answers to these questions?
A Modern Ethical Framework for Case Analysis
The advent of modern medical ethics was catalyzed by a combination of events occurring in the mid-20th century. First, there were the Nuremberg trials culminating in the Nuremberg Code detailing the ethical and moral processes and parameters of human experimentation, coupled with Dr. Henry Beecher's6 expose on medical research in the United States, and of course, the unconscionable Tuskeegee syphilis experiments. Second, the ethical and subsequent legal requirement of medical informed consent to treatment. Third, technological advances, such as the stethoscope, transformed patients from people to data sources because for the first time physicians were able to glean information from inside the human body.7 Finally, in the 1960s, the civil rights and women's movements forced the fields of medicine, theology, philosophy, and sociology to craft fundamental guidelines for medical decision making and the general application of medical technology, as patients' rights emerged and patients wrested control of their autonomy and their medical decision making from physicians. Thus, medical ethics or biomedical ethics (which includes nonmedical sciences) was born in its current, but constantly evolving, form.
From a vast, rich pool of writings and discussions by physicians, theologians, and philosophers—including notables such as Hippocrates, Saint Thomas Aquinas, and Immanuel Kant, modern biomedical ethics can be, for simplicity and this article, reduced to 3 analytical principles: beneficence/nonmalfeasance, autonomy, and justice. Increasingly, especially in the United States, these principles are overshadowed or seen through the lens of the law, as physicians, patients, and others make decisions and take actions mindful of the legal ramifications. However, in theory, these principles are to be viewed as angles of an isosceles triangle—all of equal size and importance.
Beneficence and Nonmalfeasance, Autonomy, and Justice8
Of these principles, beneficence—meaning "do good"—and nonmalfeasance—meaning "do no harm"—are most commonly known among physicians and their patients. Part of the Hippocratic Oath and numerous medical and ethical codes that followed, its value is foretold in that it is still recited at medical school graduations in the 21st century. A physician's most basic task is as caregiver and healer, which can and does take many forms. From the seeming simplicity of listening, to the dexterous complexity of transplant surgery, a physician is to abide by the principle of doing good and not harm. When medicine was a nascent field, these edicts were interpreted literally, whereas today's medical advances have metamorphosized them into a risk assessment. Thus, in reality, it has become acceptable to do some harm so long as it is outweighed by the potential good to the individual patient or society in general.
Autonomy applies both to the patient as well as the caregiver for ethical analysis and is the liberty to make one's own choices and set one's own goals herein, particularly with respect to medical decision making.9 A patient should be competent10 and free of coercion to make medical decisions on his or her own behalf. Additionally, it is important to note that within this context, veracity or truth-telling has become a fundamental underlying component of modern autonomy. Until recently, it was commonplace for a physician to lie to a patient about his or her diagnosis. After all, the concept of veracity is absent from almost all premodern medical codes, and even Plato in the Republic confidently stated, "that lies are acceptable from a physician since they are told to us for our own good—as a form of medicine."11 Similarly, the caregiver should be competent and free of coercion whether from restrictive institutional mandates, pharmaceutical company policies, or health maintenance organizations to make medical decisions that are solely his or her own (ie, which surgical technique, drug, or instrument to use) and based on his or her knowledge and medical training.
Finally, there is justice—the principle and practice of treating everyone equally and fairly. The principle of justice is a matrix of comparisons. For example, an individual patient should be treated equally and fairly as to that individual; also all patients, rich and poor, urban and remote, young and old, friend and enemy, educated and uneducated, free and enslaved, native and foreigner, should be treated judicially.12
Ethical Analysis
Medicine would never have progressed if the command to "do no harm" were literally and strictly adhered to. With advances in medicine the edict to do no harm became a balancing test, a risk assessment evaluation. There is no bright line to dictate what is too risky or ethically unacceptable in medicine, nor does this principle exist in a vacuum, but rather in conjunction with the principles of autonomy and justice and the practicalities of life. Arguments can be made that the separation surgery was ethically permissible because in the eyes of the patients and most likely the participating surgeons, performing the surgery, regardless of outcome, would be doing good and this good would outweigh the risk of harm, even death. Obviously, the converse argument can also easily be made that the surgery would not be ethically proscribed under the beneficence/nonmalfeasance principle.
Without a bright line or mathematical calculation to determine if the surgery to separate the twins was ethically acceptable with respect to doing no harm and doing good, the equally valuable principles of autonomy and justice provide insight.
If autonomy is the liberty to make one's own decisions and set one's own goals, then ethically, the sisters' decision to be separated should have been respected. Of course, not all autonomous decisions should be ethically respected. For example, the autonomous decision to injure someone else, while illegal, under most circumstances would also be ethically unjustified. However, an autonomous decision to smoke pot in one's own home and remain there, while illegal, might be ethically justified because the individual would not be harming anyone other than himself or herself. Here, each sister autonomously made the same decision, had the same goal, was fully informed, and consented. Although an argument could be made that the risks were too high, such was a decision for only the sisters to make and both assumed the risk. Just because the Bijanis' decision was ethically justified, it does not necessarily follow that the surgery should have been performed. The physicians also have a decision to make.
Being a physician does not subject one to indentured servitude. A physician's autonomy should be equally respected; as such, each individual physician's decision whether or not to participate in the surgery is ethically justifiable and should be respected given that the sisters initiated the request to be separated and they both consented.
The principle of justice simply demands that all persons be treated equally. It does not appear that there was any conundrum with respect to the principle of justice regarding the decision to undertake the operation to separate the Bijani twins. From all available information, the Bijanis were treated no differently from how anyone else would have been.
Having analyzed the Bijanis' surgery in light of the principles of autonomy and justice, this examination can be used to determine if performing the surgery was ethically in accord with doing good and doing no harm. As a result, the ethical command to respect an individual's autonomy easily tips the scale in favor of the surgery being ethically in accord with doing good and doing no harm.
In conclusion, the decision to subject oneself to a potentially lethal risk and to participate in such an endeavor does not come about easily or without internal and external conflict. In a civilized society, ethical principles, like those discussed above, are often part of the decision process. But ethical principles are relative to time and culture and are simply tools to search one's soul, guide one's hand, and focus one's mind. They are not immutable, ubiquitous laws. They function most effectively to challenge premises, catalyze debate, and advance knowledge—in this manner and in the Bijani case they are thus, invaluable.
Return to Beneficence Analysis
It is difficult to speak of true autonomy in one of the exceptionally rare cases in which the patients were not and could not be autonomous. However, such autonomy was exactly their goal. Both sisters enthusiastically and with unabated determination sought this status.
Most likely, many of us have had to make exceptionally difficult medical decisions for ourselves or for a loved one, such as whether to undergo a risky surgery or try an experimental drug therapy. Or we have watched as a friend or loved one suffered and lingered before dying. As such, it is often possible to understand the situations and dilemmas that give rise to ethical quandaries. However, the decision of the Bijanis was almost uniquely theirs. No Monday Morning QB nor ethicist nor physician should underestimate the sister's yearning to be separated or claim the risk of death too high because there are no similarly shared experiences from which to draw understanding and empathy. By definition the principle of autonomy belies an individual's inquiries and ultimate decisions concerning one's choices and goals regarding medical treatment. Each sister was fully informed of all the intricacies of the surgery and both sisters autonomously and competently consented. Thus, once the physicians felt assured that all necessary and appropriate information was relayed and evaluated and informed consent achieved, the physicians were ethical in operating and supporting each sister's autonomous choice.
Likewise, initially the physicians who operated exercised their rightful autonomy to make such a decision for themselves on the basis of their own medical knowledge, experiences, and convictions. However, ceding their autonomy to the sisters' appointed surrogate decision maker as to whether to halt the surgery and proceed in stages, a purely medical decision, was questionable at best.
If there had not been an evolution from the literal interpretation of do no harm, then critics would have a stronger argument on the basis of the ethical principle of nonmalfeasance against the surgery to separate the twins. To analyze whether the operating physicians adhered to these ancient principles requires answers to questions such as: What constitutes harm? Does all life have value or is the quality of one's life a valid decision-making criterion? How was the risk of death determined? And, who should determine if the risk outweighs the benefits? There are no easy answers to these questions; no bright lines.
As this discussion continues, the immense chasm between principle and practice will become increasingly obvious, sometimes begging the question of whether these 3 principles of biomedical ethics are of any value at all.
Footnotes
Journal of Andrology welcomes letters to the editor regarding "Forum" articles and other ethical and legal issues of interest in your own practice of research. We also invite you to suggest topics that deserve attention in future issues. Papers appearing in this section are not considered primary research reports and are thus not subjected to peer review. Unsolicited manuscripts are welcome, and will be reviewed and edited by the Section Editor. All submissions should be sent to the Journal of Andrology Editorial Office.
1 Denise Grady, 2 Women, 2 Deaths and an Ethical Quandary, New York Times, July 15, 2003; NYTimes.com.
2 Ibid.
3 Ibid.
4 Ibid.
5 Ibid.
6 Henry Beecher, Ethics and Clinical research, NEJM, June 16, 1966, vol. 274, pp 1354-1360.
7 Lecture by Drs Elizabeth Heitman and Stanley Reiser, Ethics in Medicine, University of Texas Medical School, August 31, 1995.
8 Sissela Bok, The Tools of Bioethics, 1997, pp 137-141.
9 Ibid. at 139.
10 Decision making on behalf of an incompetent patient, whether because of mental limitation or unconsciousness, although deserving of discussion, is only relevant here to the extent that the Bijani twins, while competent, appointed a substitute decision maker for when they were unable to do so. Therefore, in this limited scope there is no ethical conflict because the substitute was chosen personally by the twins; whether the substitute decision maker acted ethically and in accordance with the sisters' wishes will forever remain unknown.
11 Plato, Republic, (Harvard University Press) 1930, p 389 b-d
12 See eg, Canon of Medicine, Han Dynasty, China 200 BC-200 AD.(Twin Autonomy SUSAN KERR )
Ladden and Laleh Bijani were 29-year-old Iranian twin sisters conjoined at the head. Educated, spirited, ambitious, and singularly determined to lead individual lives, they sought to be separated. Some doctors rejected their plea for separation, while others tried to dissuade them because of the high risk of death for either or both of the sisters. Finally, because of their stoic persistence in pursuit of their singular goal to completely be two, a team of physicians assembled at Raffles Hospital in Singapore. With grins from ear to ear, the women eagerly entered the hospital and excitedly embraced the surgery. Although ultimately separated, they never got to revel in achieving their goal of total autonomy. Sadly, both women bled to death during the 50-hour surgery.
As with most efforts that end in tragedy, the "Monday Morning Quarterbacks (QBs)" began their pontifications shortly thereafter. For example, Mark Siegler of the University of Chicago's Maclean Ethics Center stated plainly that despite the twins [informed] consent, the operation violated ethical standards for experimental surgery because it was not medically necessary and the 50% risk of death was "too high".1 He further elaborated to justify his position, that, "you need more than an autonomous choice on the part of the patient[s],... you need responsible judgement on the part of the surgeon."2 Where Monday Morning QB Siegler expressed ethical concerns, Dr. Benjamin Carson, a Johns Hopkins pediatric neurosurgeon, who initially felt compelled to help the twins because he "was convinced they would seek separation no matter who performed the surgery,"3 expressed technical medical concerns. The operation, he opined, should have been performed in "stages over the course of weeks" rather than "all at once".4 The need for a change in procedure became apparent during the operation and given such, the physicians contemplated stopping, placing the twins in intensive care, and proceeding with the surgery in stages. However, instead of heeding their own medical judgment, the physicians consulted the representative the twins had appointed to make decisions, on their behalf, when they were unable to do so. Because the representative insisted, "the sisters would want the separation to proceed no matter what,"5 the physicians continued.
Other than hindsight and personal opinion, do these arguments have merit? Should separating otherwise healthy adults conjoined at the head ever be undertaken? Were the high risk of death and the physicians ceding their medical decision-making autonomy to the sisters' representative the only medical/ethical concerns? Whose ethical standards take precedent? The sisters'? The physicians'? Western medicine's? Are there any universal answers to these questions?
A Modern Ethical Framework for Case Analysis
The advent of modern medical ethics was catalyzed by a combination of events occurring in the mid-20th century. First, there were the Nuremberg trials culminating in the Nuremberg Code detailing the ethical and moral processes and parameters of human experimentation, coupled with Dr. Henry Beecher's6 expose on medical research in the United States, and of course, the unconscionable Tuskeegee syphilis experiments. Second, the ethical and subsequent legal requirement of medical informed consent to treatment. Third, technological advances, such as the stethoscope, transformed patients from people to data sources because for the first time physicians were able to glean information from inside the human body.7 Finally, in the 1960s, the civil rights and women's movements forced the fields of medicine, theology, philosophy, and sociology to craft fundamental guidelines for medical decision making and the general application of medical technology, as patients' rights emerged and patients wrested control of their autonomy and their medical decision making from physicians. Thus, medical ethics or biomedical ethics (which includes nonmedical sciences) was born in its current, but constantly evolving, form.
From a vast, rich pool of writings and discussions by physicians, theologians, and philosophers—including notables such as Hippocrates, Saint Thomas Aquinas, and Immanuel Kant, modern biomedical ethics can be, for simplicity and this article, reduced to 3 analytical principles: beneficence/nonmalfeasance, autonomy, and justice. Increasingly, especially in the United States, these principles are overshadowed or seen through the lens of the law, as physicians, patients, and others make decisions and take actions mindful of the legal ramifications. However, in theory, these principles are to be viewed as angles of an isosceles triangle—all of equal size and importance.
Beneficence and Nonmalfeasance, Autonomy, and Justice8
Of these principles, beneficence—meaning "do good"—and nonmalfeasance—meaning "do no harm"—are most commonly known among physicians and their patients. Part of the Hippocratic Oath and numerous medical and ethical codes that followed, its value is foretold in that it is still recited at medical school graduations in the 21st century. A physician's most basic task is as caregiver and healer, which can and does take many forms. From the seeming simplicity of listening, to the dexterous complexity of transplant surgery, a physician is to abide by the principle of doing good and not harm. When medicine was a nascent field, these edicts were interpreted literally, whereas today's medical advances have metamorphosized them into a risk assessment. Thus, in reality, it has become acceptable to do some harm so long as it is outweighed by the potential good to the individual patient or society in general.
Autonomy applies both to the patient as well as the caregiver for ethical analysis and is the liberty to make one's own choices and set one's own goals herein, particularly with respect to medical decision making.9 A patient should be competent10 and free of coercion to make medical decisions on his or her own behalf. Additionally, it is important to note that within this context, veracity or truth-telling has become a fundamental underlying component of modern autonomy. Until recently, it was commonplace for a physician to lie to a patient about his or her diagnosis. After all, the concept of veracity is absent from almost all premodern medical codes, and even Plato in the Republic confidently stated, "that lies are acceptable from a physician since they are told to us for our own good—as a form of medicine."11 Similarly, the caregiver should be competent and free of coercion whether from restrictive institutional mandates, pharmaceutical company policies, or health maintenance organizations to make medical decisions that are solely his or her own (ie, which surgical technique, drug, or instrument to use) and based on his or her knowledge and medical training.
Finally, there is justice—the principle and practice of treating everyone equally and fairly. The principle of justice is a matrix of comparisons. For example, an individual patient should be treated equally and fairly as to that individual; also all patients, rich and poor, urban and remote, young and old, friend and enemy, educated and uneducated, free and enslaved, native and foreigner, should be treated judicially.12
Ethical Analysis
Medicine would never have progressed if the command to "do no harm" were literally and strictly adhered to. With advances in medicine the edict to do no harm became a balancing test, a risk assessment evaluation. There is no bright line to dictate what is too risky or ethically unacceptable in medicine, nor does this principle exist in a vacuum, but rather in conjunction with the principles of autonomy and justice and the practicalities of life. Arguments can be made that the separation surgery was ethically permissible because in the eyes of the patients and most likely the participating surgeons, performing the surgery, regardless of outcome, would be doing good and this good would outweigh the risk of harm, even death. Obviously, the converse argument can also easily be made that the surgery would not be ethically proscribed under the beneficence/nonmalfeasance principle.
Without a bright line or mathematical calculation to determine if the surgery to separate the twins was ethically acceptable with respect to doing no harm and doing good, the equally valuable principles of autonomy and justice provide insight.
If autonomy is the liberty to make one's own decisions and set one's own goals, then ethically, the sisters' decision to be separated should have been respected. Of course, not all autonomous decisions should be ethically respected. For example, the autonomous decision to injure someone else, while illegal, under most circumstances would also be ethically unjustified. However, an autonomous decision to smoke pot in one's own home and remain there, while illegal, might be ethically justified because the individual would not be harming anyone other than himself or herself. Here, each sister autonomously made the same decision, had the same goal, was fully informed, and consented. Although an argument could be made that the risks were too high, such was a decision for only the sisters to make and both assumed the risk. Just because the Bijanis' decision was ethically justified, it does not necessarily follow that the surgery should have been performed. The physicians also have a decision to make.
Being a physician does not subject one to indentured servitude. A physician's autonomy should be equally respected; as such, each individual physician's decision whether or not to participate in the surgery is ethically justifiable and should be respected given that the sisters initiated the request to be separated and they both consented.
The principle of justice simply demands that all persons be treated equally. It does not appear that there was any conundrum with respect to the principle of justice regarding the decision to undertake the operation to separate the Bijani twins. From all available information, the Bijanis were treated no differently from how anyone else would have been.
Having analyzed the Bijanis' surgery in light of the principles of autonomy and justice, this examination can be used to determine if performing the surgery was ethically in accord with doing good and doing no harm. As a result, the ethical command to respect an individual's autonomy easily tips the scale in favor of the surgery being ethically in accord with doing good and doing no harm.
In conclusion, the decision to subject oneself to a potentially lethal risk and to participate in such an endeavor does not come about easily or without internal and external conflict. In a civilized society, ethical principles, like those discussed above, are often part of the decision process. But ethical principles are relative to time and culture and are simply tools to search one's soul, guide one's hand, and focus one's mind. They are not immutable, ubiquitous laws. They function most effectively to challenge premises, catalyze debate, and advance knowledge—in this manner and in the Bijani case they are thus, invaluable.
Return to Beneficence Analysis
It is difficult to speak of true autonomy in one of the exceptionally rare cases in which the patients were not and could not be autonomous. However, such autonomy was exactly their goal. Both sisters enthusiastically and with unabated determination sought this status.
Most likely, many of us have had to make exceptionally difficult medical decisions for ourselves or for a loved one, such as whether to undergo a risky surgery or try an experimental drug therapy. Or we have watched as a friend or loved one suffered and lingered before dying. As such, it is often possible to understand the situations and dilemmas that give rise to ethical quandaries. However, the decision of the Bijanis was almost uniquely theirs. No Monday Morning QB nor ethicist nor physician should underestimate the sister's yearning to be separated or claim the risk of death too high because there are no similarly shared experiences from which to draw understanding and empathy. By definition the principle of autonomy belies an individual's inquiries and ultimate decisions concerning one's choices and goals regarding medical treatment. Each sister was fully informed of all the intricacies of the surgery and both sisters autonomously and competently consented. Thus, once the physicians felt assured that all necessary and appropriate information was relayed and evaluated and informed consent achieved, the physicians were ethical in operating and supporting each sister's autonomous choice.
Likewise, initially the physicians who operated exercised their rightful autonomy to make such a decision for themselves on the basis of their own medical knowledge, experiences, and convictions. However, ceding their autonomy to the sisters' appointed surrogate decision maker as to whether to halt the surgery and proceed in stages, a purely medical decision, was questionable at best.
If there had not been an evolution from the literal interpretation of do no harm, then critics would have a stronger argument on the basis of the ethical principle of nonmalfeasance against the surgery to separate the twins. To analyze whether the operating physicians adhered to these ancient principles requires answers to questions such as: What constitutes harm? Does all life have value or is the quality of one's life a valid decision-making criterion? How was the risk of death determined? And, who should determine if the risk outweighs the benefits? There are no easy answers to these questions; no bright lines.
As this discussion continues, the immense chasm between principle and practice will become increasingly obvious, sometimes begging the question of whether these 3 principles of biomedical ethics are of any value at all.
Footnotes
Journal of Andrology welcomes letters to the editor regarding "Forum" articles and other ethical and legal issues of interest in your own practice of research. We also invite you to suggest topics that deserve attention in future issues. Papers appearing in this section are not considered primary research reports and are thus not subjected to peer review. Unsolicited manuscripts are welcome, and will be reviewed and edited by the Section Editor. All submissions should be sent to the Journal of Andrology Editorial Office.
1 Denise Grady, 2 Women, 2 Deaths and an Ethical Quandary, New York Times, July 15, 2003; NYTimes.com.
2 Ibid.
3 Ibid.
4 Ibid.
5 Ibid.
6 Henry Beecher, Ethics and Clinical research, NEJM, June 16, 1966, vol. 274, pp 1354-1360.
7 Lecture by Drs Elizabeth Heitman and Stanley Reiser, Ethics in Medicine, University of Texas Medical School, August 31, 1995.
8 Sissela Bok, The Tools of Bioethics, 1997, pp 137-141.
9 Ibid. at 139.
10 Decision making on behalf of an incompetent patient, whether because of mental limitation or unconsciousness, although deserving of discussion, is only relevant here to the extent that the Bijani twins, while competent, appointed a substitute decision maker for when they were unable to do so. Therefore, in this limited scope there is no ethical conflict because the substitute was chosen personally by the twins; whether the substitute decision maker acted ethically and in accordance with the sisters' wishes will forever remain unknown.
11 Plato, Republic, (Harvard University Press) 1930, p 389 b-d
12 See eg, Canon of Medicine, Han Dynasty, China 200 BC-200 AD.(Twin Autonomy SUSAN KERR )